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Next Generation Tactics for 510(k) Submissions

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by

Juan Carlos Serna

on 21 March 2018

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Transcript of Next Generation Tactics for 510(k) Submissions

Agenda
Challenges of a 510(k)
Anatomy of a 510(k)
Root causes of delays
How to prevent delays
Case studies
You could Google "how to write a 510(k)"
34% of the 4,000 510(k)s submitted each year are administratively incomplete
Average of 2.5 months delay
$850 million value loss
Causes of Delays
The Problem
Preparation of a 510(k):
Tactics for 510(k) Submissions
Utilizing software for a smarter and faster submission
Case Studies

Undocumented causes of delays:
Last minute changes to Indications for Use, trade name, etc.
Need for additional testing or justification is often discovered right before submission
Internal review cycles

Anatomy of a 510(k)
Shelf Life
Prior Submissions
Consistent Indications
Test Reports
Despite all of this...
You could also try "FDA 510(k) guidance documents," where you'll return 187 results:
Predicate Comparison
www.rightsubmission.com
From Feb-April 2014 FDA 510(k) RTA Audit.
Tools to work smarter and faster
MS Word templates
Defined work flows
Software
10 days from start to finish
Early start, early course correction
Technology to address anticipated problem

Last minute discussion with FDA opened door for immediate submission
10 days from start to finish
Team
Quality Engineer
VP RA/QA
Mgr RA/QA
Intern
FDA Consultant
How It Happened
No emailing of documents
Common collaboration platform
Focused submission
Good mix of time and talent
Frequent check-ins
Critically think through the content of each section and ask the team:
Complex, time consuming, and manual process
510(k) regulations are complex and not always logical.
No defined workflow
FDA reviewers are civil servants
Multi-disciplinary process
VC/grant funded company, urgency was dramatic
Own predicate with established library of documents
Goal of 10 day submission was set by CEO
Early start, early course correction
Starting early, early course correction
Identified testing gaps early
Obtained documentation from vendor bridging standard revisions
This would have caused a few weeks' delay if not caught early
Summary
510(k) regulations and submissions are complex
With proper planning and tools the process does not have to be painful
Delays are predictable and preventable
1. What tests and reports are we including?
2. Why are we including them, how does it support a SE decision?

3. Are they up-to-date?
4. Is the product tested comparable to the product under review?
5. What are the weak spots and how do we address them?
Case Study 1
Case Study 2
Full transcript